Saturday, July 23, 2022 3:38:29 PM
Over the past decade I have written a great deal about first-, second- and third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer (NSCLC), so that portion of this sample press release is very familiar to me.
In your example the drug name, aumolertinib, is not familiar since it is still so new. But other parts of the press release, where they are talking about various steps in the United Kingdom (UK) regulatory review process, are unfamiliar as well. I normally write about drugs advancing through US Food and Drug Administration (FDA) regulatory review. Furthermore, it appears that even if I'd been writing about new cancer drugs advancing through the UK Medicines and Healthcare products Regulatory Agency (MHRA) regulatory approval process for many years, there are portions of this press release that would still be unfamiliar, since the UK process has changed very recently.
I think the best example is what you abbreviated with the shorthand term ILAP, which stands for Innovative Licensing and Access Pathway. Apparently the ILAP didn't even exist until last year. So, I think we can all be forgiven (especially shareholders in the United States and other countries outside the UK) for feeling a bit clueless/uncertain as we seek to follow the regulatory journey of DCVax-L. So many new acronyms to learn!
It's especially confusing when the acronyms are so similar. I'm thinking now of MAA and MIAA, which I now gather refer to a marketing authorization application and a manufacturing/importing authorization application, respectively. (If I understand things correctly, as of July 6 Northwest had submitted the MIAA but not the MAA. Translated, that means Northwest has applied for manufacturing approval for the Sawston factory, but not marketing approval for DCVax-L, its lead product candidate.)
Speaking of regulatory journeys, when I submitted a proposal about DCVax-L to the "public suggestion box" (my term, not theirs) of the National Comprehensive Cancer Network (NCCN), the anonymous employee who responded to my suggestion inquired about the regulatory status. I took the employee's question to be a good sign, and I will submit a future post with more details about this.
Recent NWBO News
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